Contributions of Self-Focused Attention to Early Warning Indicators of Cognitive Behavioral Therapy Non-Response
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Trait SFA assessed by the Public Self-Consciousness Scale- Revised (SCS-R)
研究概览
简要总结
The purpose of this study is to understand why some individuals respond fully to cognitive behavioral therapy and others do not, based on multiple sources of data such as neural, neurocognitive, clinical, and self-report data.
详细描述
The investigators are conducting this research to evaluate the reliability and construct validity of measures of self-focused attention (SFA) across neural, neurocognitive, and self-report levels of analysis as well as examine whether early changes in the SFA biomarker are associated with CBT non-response.
This will be looked at in a clinical population consisting of individuals with social anxiety disorder (SAD) and body dysmorphic disorder (BDD) compared to healthy volunteers. This study employs an open clinical trial for cognitive behavioral therapy with pre-, mid- and post-treatment neuroimaging scans, clinical interviews, neurocognitive, behavioral, and self-report assessments. Clinical participants will be invovled for 3.5 months and complete 12 CBT sessions and 4 fMRI scans. Control participants will not participate in CBT treatment and will complete 3 fMRI scans across a 3.5 month period. About 160 people will take part in this research study, all at the University of Washington (UW). This will include 110 clinical participants and 50 healthy control participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical sample (N=110):
- •Men and women, age 18-45
- •Treatment-seeking individuals who meet criteria for a primary DSM-5 diagnosis of primary social anxiety disorder (SAD) or body dysmorphic disorder (BDD) based on the SCID-5-RV
- •Fluent in English and willing to provide informed consent.
- •Control sample (N=50):
- •Men and women, age 18-45
- •No current or lifetime history of psychiatric disorders, as assessed using the SCID-5-RV
- •Meet criteria for low levels of anxiety (GAD-7 score of <8) and depression (PHQ-9 score <10)
- •Fluent in English and willing to provide informed consent
排除标准
- •All groups:
- •Score < 80 based on WRAT5 Word Reading Subtest
- •fMRI contraindications (e.g., electronic medical devices such as pacemakers, implanted defibrillators, etc.; metal implants not approved for MRI; pregnancy; claustrophobia)
- •2. Active suicidal or homicidal ideation, or any features requiring a higher level of care
- •Lifetime history of manic or hypomanic episode, psychotic symptoms, traumatic brain injury, neurological disorder, pervasive developmental disorder, or attention deficit-hyperactivity disorder; active alcohol or substance use disorder in the past 6 months
- •Current use of psychotropic medications, except antidepressants taken at a stable dose for 3 months prior to study baseline
- •Previous CBT non-responder or current CBT
研究组 & 干预措施
Cognitive behavioral therapy
Twelve weekly sessions of individual cognitive behavioral therapy
干预措施: Cognitive Behavioral Therapy (Behavioral)
结局指标
主要结局
Trait SFA assessed by the Public Self-Consciousness Scale- Revised (SCS-R)
时间窗: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment
Participants will complete the 7-item self-report Public SCS-R measure to assess trait self-focused attention.
Functional connectivity between the Default Mode and Dorsal Attention Networks (DMN-DAN)
时间窗: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment
Participants will complete an MRI scan comprising both task and resting state fMRI to derive a measure of intrinsic functional connectivity between DMN and DAN using general functional connectivity.
Anxiety symptom severity, assessed by the Structured Interview Guide for Hamilton Anxiety Scale (SIGH-A) and the Generalized Anxiety Disorder (GAD-7)
时间窗: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment
The SIGH-A is a 14-item clinician-rated assessment of past-week anxiety symptom severity. Scores on the SIGH-A (together with scores on the CGI-I) will be used to calculate a categorical measure of treatment response (e.g., Remitters, Partial Responders, or NonResponders). SIGH-A items will be adapted to accommodate anxiety symptoms in a transdiagnostic sample (e.g., accounting for specific disorder-relevant fears in item 3, such as fear of negative appearance evaluation in BDD). Generalized Anxiety Disorder (GAD-7) is a 7-item self-report measure of severe anxiety
Anxiety symptom severity, assessed by the Generalized Anxiety Disorder (GAD-7)
时间窗: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment
Generalized Anxiety Disorder (GAD-7) is a 7-item self-report measure of severe anxiety
Symptom severity associated with primary disorder, assessed by self-report versions of the Liebowitz Social Anxiety Scale (LSAS SR).
时间窗: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment. DSM5 Cross Cutting: Baseline (T-2weeks), Repeat Baseline (T0), Post-treatment
Total scores from the LSAS-SR will be used toward calculating a categorical measure of treatment response (e.g., Remitters, Partial Responders, or NonResponders). Scores will also be examined as a dimensional measure of symptom severity change during treatment based on the participant's primary disorder. Standardized change scores will be calculated based on the pretreatment score on the selected measure.
Symptom severity associated with primary disorder, assessed by self-report version of the Yale-Brown Obsessive-Compulsive Scale Modified for BDD (BDD-YBOCS SR).
时间窗: Across the span of 3 1/2 months: BDD-YBOCS: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment. DSM5 Cross Cutting: Baseline (T-2weeks), Repeat Baseline (T0), Post-treatment
Total scores from the BDD-YBOCS-SR will be used toward calculating a categorical measure of treatment response (e.g., Remitters, Partial Responders, or NonResponders). Scores will also be examined as a dimensional measure of symptom severity change during treatment based on the participant's primary disorder. Standardized change scores will be calculated based on the pretreatment score on the selected measure.
DSM5 Cross Cutting Form
时间窗: Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment. DSM5 Cross Cutting: Baseline (T-2weeks), Repeat Baseline (T0), Post-treatment
The DSM-5 Cross Cutting Measure is a 24-item self-report measure that assesses symptom related problems over the past 2 weeks.
次要结局
- Trait rumination assessed by the Ruminative Responses Scale (RRS)(Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment)
- Reaction times during Self trials in Self-Other Task(Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment)
- Trait worry assessed by the Penn State Worry Questionnaire (PSWQ)(Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment)
- Alerting, orienting, and attentional control reaction time scores on the Attention Network Test (ANT)(Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment)
- Depression severity, as assessed by the Quick Inventory of Depressive Symptomatology (QIDS-SR)(Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment)
- Depression severity, as assessed by the Patient Health Questionnaire-9 (PHQ-9)(Across the span of 3 1/2 months: PHQ-9: Baseline (T-2weeks), Repeat Baseline (T0), and Weekly starting from Week 1.)
- Insight, as assessed by the Brown Assessment of Beliefs Scale (BABS)(Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 3, Week 6, Week 9, Post-treatment)
- Disability, assessed by the Sheehan Disability Scale (SDS).(Across the span of 3 1/2 months: Baseline (T-2weeks), Repeat Baseline (T0), Week 6, Post-treatment.)
- Disability, assessed by the World Health Organization Disability Assessment Schedule (WHODAS)(Across the span of 3 1/2 months: Baseline (T-2 weeks), Repeat Baseline (T0), Post-treatment)
- Homework compliance, assessed by a modified version of the Patient Exposure/Response Prevention Adherence Scale (PEAS)(Weekly starting from Week 1 to Week 12)
- Credibility and expectancies for treatment, assessed by the Credibility and Expectancies Questionnaire (CEQ)(Week 3)
研究者
Angela Fang
Associate Professor of Psychology
University of Washington